D-RAD SMART PACK 71158019Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556364444), received between Jan 25, 2022 and Mar 30, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K132296, K210837, K213126); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED A SUPERFICIAL WOUND INFECTION SIX (6) MONTHS POSTOPERATIVELY. THE PATIENT REQUIRED TREATMENT WITH IV FLUCLOXACILLIN FOR FOUR (4) DAYS BEFORE CONVERSION TO ORAL FLUCLOXACILLIN FOR FURTHER SEVEN (7) DAYS. THIS SYMPTOM WAS FULLY RESOLVED UPON TREATMENT. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE ONE (1) MONTH POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16650348 ↗
• InjuryOct 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY THE PLATE REMOVAL, WASHOUT AND BRIDGING WITH AN EXTERNAL FIXATOR. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR (9) MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOM AND THE ADDITIONAL SURGERY PERFORMED WAS NOT PROVIDED. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE (4) MONTHS POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15656087 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ONE PATIENT WHO UNDERWENT AN INTERNAL FIXATION SURGERY ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM EXPERIENCED THE THUMB EXTENSOR TENDON (EPL) RUPTURE. IT IS UNKNOWN IF THIS INCIDENT OCCURRED INTRAOPERATIVELY OR POSTOPERATIVELY, AS WELL AS ANY MEASURES TAKEN TO RESOLVE THE COMPLICATION. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE TWO (2) MONTHS POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Pain; Rupture

  MAUDE report 15636293 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED NOTABLE PAIN, AN UNEXPECTED DECREASE IN RANGE OF MOTION OF THE WRIST AND A BONE COLLAPSE IN AN UNSPECIFIED REGION OF THE WRIST. A PLATE REMOVAL WAS REQUIRED TO TREAT THIS ADVERSE EVENT. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR TWO (2) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOMS IS NOT KNOWN. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 2 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Necrosis; Pain

  MAUDE report 15636254 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT SUSTAINED PAIN THAT MADE NECESSARY THE REMOVAL OF THE PLATE. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR TEN (10) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED SYMPTOMS AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 2 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Impaired Healing; Inflammation; Pain

  MAUDE report 15636119 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT EXPERIENCED THE RUPTURE OF THE FLEXOR POLLICIS LONGUS TENDON WHICH REQUIRED THE PLATE REMOVAL ON AN UNKNOWN DATE. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 15636028 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTERNAL FIXATION SURGERY PERFORMED ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM, THE PATIENT REQUIRED THE REMOVAL OF THE PLATE DUE TO PAIN. ALTHOUGH THE PATIENT WAS FOLLOWED UP FOR THIRTY TWO (32) POSTOPERATIVE MONTHS, AN ONSET DATE FOR THE REPORTED PAIN AND A DATE OF SURGERY FOR THE PLATE REMOVAL IS NOT KNOWN. THE PATIENT HAD ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE 1.5 MONTHS POST INITIAL IMPLANTATION AND WAS REPORTED AS "FULL RETURN TO DUTY" STATUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Pain; Rupture

  MAUDE report 15635399 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ONE PATIENT WHO UNDERWENT AN INTERNAL FIXATION SURGERY ON AN UNSPECIFIED DATE TO TREAT A RADIUS FRACTURE WITH A D-RAD SINGLE USE KIT PLATING SYSTEM EXPERIENCED THE THUMB EXTENSOR TENDON (EPL) RUPTURE AND REQUIRED THE REMOVAL OF THE PLATING SYSTEM. AN ONSET DATE FOR THE REPORTED COMPLICATION AND THE DATE OF PLATE REMOVAL SURGERY WERE NOT PROVIDED. THE PATIENT ACHIEVED RADIOGRAPHIC UNION OF THE FRACTURE TWO (2) MONTHS POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Rupture

  MAUDE report 15635274 ↗
• MalfunctionAug 11, 2022Corroded; Corroded

  IT WAS REPORTED THAT, WHILE SETTING UP FOR AN INTERNAL FIXATION, THE SCREWDRIVERS OF THE FOLLOWING PLATE KITS WERE NOTICED WITH RUST: D-RAD SMART PACK 4H LEFT STANDARD PLATE, D-RAD SMART PACK 4H LEFT WIDE PLATE, D-RAD SMART PACK 4H RIGHT STANDARD PLATE AND TWO D-RAD SMART PACK 4H RIGHT WIDE PLATES. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE SO SURGERY STARTED ON TIME. THE PATIENT WAS NOT AFFECTED BY THE FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213734 ↗
• InjuryJan 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A D-RAD SMART PACK 4H LEFT STANDARD PLATE SPLIT DURING SCREW INSERTION. ALL PIECES WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343504 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132296, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2018 · Mar 7, 2018 · Terminated
  D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERI
• Z-1856-2017 · Mar 9, 2017 · Terminated
  D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
• Z-1857-2017 · Mar 9, 2017 · Terminated
  D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM
• Z-1855-2017 · Mar 9, 2017 · Terminated
  D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic